moderate to severe covid-19 patients. COVID-19, virus identified
Conditions
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Aged 40-65 years Voluntarily participate in this clinical trial and sign off "informed consent form" Chest imaging confirm COVID-19 featured lesions in the lung The SARS-CoV-2 nucleic acid test was positive Diagnosed with severe pneumonia of COVID-19: respiratory distress, Respiratory rate (RR) = 30 times/min; resting oxygen saturation of 90% or less; arterial pressure of oxygen/the fraction of inspired oxygen= 300 mmHg; pulmonary imaging of focus within 24-48 hours > 50% progression Patients with a diagnosis of moderate pneumonia caused by Covid-19: 1- Presence of respiratory symptoms (including shortness of breath, feeling of pain and pressure in the chest, ...) with or without fever equal to / greater than 38 ° C 2- Percentage of blood oxygen saturation in Room air at rest between 90 to 93% 3-Pulmonary infiltration less than 50%
Exclusion criteria
Exclusion criteria: History of drug reactions or allergies Pneumonia caused by bacteria, Mycoplasma, Chlamydia, Legionella, fungi, or other viruses Airway obstruction due to lung cancer or unknown factors Carcinoid syndrome History of epilepsy and long-term use of anticonvulsant drugs during the last 3 years History of long-term use of immunosuppressive drugs History of chronic respiratory illness that requires long-term oxygen therapy The patient is on blood or peritoneal dialysis Creatinine clearance 12) History of deep vein thrombosis (DVT) or pulmonary embolism over the past 3 years Being under ECMO or high-frequency oscillatory ventilation support Diagnostic of HIV, hepatitis B, and syphilis Pregnant or lactating women Lack of consciousness and inability to provide informed consent by the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in serum CRP levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Decrease in serum levels of lactate dehydrogenase. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Decrease in serum D-Dimer levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Decrease in lymphopenia percentage. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Reduce the size of the lesion on CT scan of the lungs. Timepoint: En On days 0, 10, 28 after the first intervention. Method of measurement: CT Scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improving respiratory efficiency. Timepoint: Before the intervention until the one month after the first intervention on a daily basis. Method of measurement: Measuring PaO2 / FiO2 ratio or percentage of blood oxygenation.;Increasing the number of patients weaning from mechanical ventilation. Timepoint: Daily for one month after the first injection. Method of measurement: Observation.;Reduce the number of days hospitalized in the ICU. Timepoint: Daily for one month after the first injection. Method of measurement: Observation.;Reducing the incidence of failure of various organs. Timepoint: Daily for one month after the first injection. Method of measurement: Observation.;Reduce mortality rate. Timepoint: Daily for one month after the first injection. Method of measurement: Counting people. | — |
Countries
Iran (Islamic Republic of)
Contacts
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Tehran University of Medical Sciences
Outcome results
None listed